Trials / Completed
CompletedNCT00374777
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Placebo- and Nitrazepam-Controlled, Group-Comparison Study in Patients With Insomnia Associated With Schizophrenia and Manic-Depressive Psychosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 20 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zolpidem MR | oral |
| DRUG | nitrazepam | oral |
| DRUG | placebo | oral |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2008-05-01
- Completion
- 2008-06-01
- First posted
- 2006-09-11
- Last updated
- 2014-08-20
Locations
6 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00374777. Inclusion in this directory is not an endorsement.